Plain English Summary

Background and study aimsPlatelets are the component of blood which helps the blood to clot. People with low platelet counts are vulnerable to bleeding. Approximately one third of patients in intensive care have a low platelet count and the majority undergo at least one invasive procedure during their time in intensive care. Desmopressin is a medication commonly used for congenital (from birth) bleeding disorders such as haemophilia and von Willebrand disease and it has few side effects. This study aims to assess the feasibility of administering desmopressin to these patients with low platelet counts before they undergo surgery.

Who can participate?Adults with low platelet counts who are scheduled to have an interventional procedure (a procedure that involves making a cut in the body).

What does the study involve?Participants are randomly allocated to receive a single dose through drip of either desmopressin or placebo (dummy drug), prior they have their interventional procedure. The surgery is conducted according to standard practice. Blood samples are collected before the treatment, and at 30 minutes and 120 minutes after treatment. Participant progress is checked after 24 hours, then at 7 days, and at 28 days after the treatment.

What are the possible benefits and risks of participating?Administering desmopressin may prevent procedure-related serious bleeding events, but at present it is not known if this will be the case. It has proven to be effective at reducing bleeding for people who are undergoing surgery, but this trial will look at whether it will also work well for Intensive Care patients. Some patients may experience facial flushing (redness in the face), nausea (feeling sick) or stomach pain, or headache. Rarely people will get a low blood pressure during the infusion of desmopressin. Some people may develop low levels of salt (sodium) in their blood after they receive desmopressin. Very rarely (in less than 1 in 10,000 people) desmopressin may cause very low salt levels which can lead to seizures. Very rarely desmopressin could cause an allergic reaction. Participants will be closely monitored for any evidence of these side-effects.

Where is the study run from? NHS Blood and Transplant Clinical Trials Unit (UK)

When is the study starting and how long is it expected to run for? January 2016 to December 2018

Patient information sheet

Condition

Intervention

Following provision of informed consent, participants will be randomised to receive a single intravenous infusion of either desmopressin (0.3 micrograms per kg, made up to 50mL with saline) or placebo (50mL saline). All participants will be followed-up until Day 28 post-treatment.

Intervention type

Drug

Phase

Drug names

Demopressin

Primary outcome measure

Proportion of eligible patients who are randomised and receive the IMP is assessed by analysis of screening and recruitment data at the end of the study.

Secondary outcome measures

1. Adherence to protocol measured at 28 days post-treatment, measured by analysis of Case Report Forms at the end of the study2. Time taken to administer IMP (from randomisation), measured by analysis of Case Report Forms at the end of the study3. Difference in change in percentage aggregation of platelets in microfluidics chamber between desmopressin and placebo before and after IMP, measured by blood tests at pre-treatment, 30 minutes post-treatment and 120 minutes post-treatment4. Difference in change in PFA-200 closure time for ADP/collagen and P2Y cartridges between desmopressin and placebo before and after IMP, measured by blood tests at pre-treatment, 30 minutes post-treatment and 120 minutes post-treatment5. Difference in change in thrombin generation, between desmopressin and placebo before and after IMP, measured by blood tests at pre-treatment, 30 minutes post-treatment and 120 minutes post-treatment6. Bleeding up to 24 hours after administration of IMP, measured using the HEME (Haemorrhage Measurement Tool) Bleeding Assessment at 24 hours7. Thromboembolic events up to 28 days after administration of IMP, measured by reviewing patient notes at Day 1, Day 7 and Day 28. 8. Exposure to blood products (red cell transfusion, platelet transfusion) up to 24 hours after administration of IMP, measured by reviewing patient notes at Day 1

Overall trial start date

01/01/2016

Overall trial end date

30/06/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 18 years and over2. Platelet count less than or equal to 100 x 10^9/L3. Inpatient on a critical care ward4. Due to undergo an invasive procedure

Website

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Results and Publications

Publication and dissemination plan

Plan to publish the study results in a peer-reviewed journal, as soon as possible following database lock.

IPD Sharing plan:The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Intention to publish date

30/06/2020

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

LM 03/08/2018: The following changes have been made to the trial record:
1. The overall trial end date was changed from 31/01/2019 to 30/06/2019
2. The recruitment end date was changed from 30/04/2018 to 30/05/2019
3. The intention to publish date was changed from 31/12/2017 to 30/06/2020